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HHS/FDA RIN: 0910-AG71 Publication ID: Spring 2011 
Title: ●Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products 
Abstract: This rule finalized the interim final rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000. This rule amends FDA regulation on protection of human subjects (21 CFR Part 50) and institutional review boards (21 CFR Part 56) to provide additional safeguards for children enrolled in clinical investigation of FDA regulated trials. Compared to the interim final rule, this final rule makes minor editorial changes and a small number of substantive changes in response to comments received on the interim rule. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 50    21 CFR 56   
Legal Authority: 21 USC 343    21 USC 350a    21 USC 350b    21 USC 352 to 353    21 USC 355    21 USC 360j    21 USC 371    42 USC 262   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  04/24/2001  66 FR 20589   
Final Action  10/00/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Robert "Skip" Nelson
Lead Medical Officer
Department of Health and Human Services
Food and Drug Administration
WO 32, Room 5126, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-8665
Email: robert.nelson@fda.hhs.gov